Balancing needs and resources in medicines delivery

The ChallengeNOW and into the future

Shaun Flanagan,Corporate Pharmaceutical Unit

Medicine Supply: Core Principles 2006 Public access to innovative and other

medicines through reimbursement based on: affordability sustainability continuity and security of

supply value for money

Strategic view / available resources

Making Room for Innovation:Finding the Balance 2006 IPHA agreement

Pricing new products: expanded basket reviews: early launch patent expiry: price reductions

Health technology assessment (HTA) clinical innovation, benefits new or existing therapies budget impact

2006 Agreement

€250M reduction in the rate of escalation over 4 years (Clause 6)

Not a net reduction in costs to the state

All reductions re-invested by the state in the provision of medicines

High Tech arrangements

4049

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Where are we now?

Where are we likely to go?

2009 Economic Reality

Department of Finance Monthly Economic Bulletin November 2009

Projecting the Impact of Demographic Change on the Demand for and Delivery of Healthcare in Ireland

Layte, Richard (ed.) Barry, Michael (TCD) Bennett, Kathleen (TCD) Brick, Aoife Morgenroth, Edgar Normand, Charles (TCD) O'Reilly, Jacqueline Thomas, Stephen (TCD) Tilson, Leslie (TCD) Wiley, Miriam M Wren, Maev-Ann (TCD)

2006 → 2020 (ITEMS 2021)

Current use model Items increase from 54M → 75M Ingredient costs €1.1Bn → €1.5Bn

Projected use model Items increase from 54M → 110M Ingredient costs €1.1Bn → €2.4Bn

Limitations of Predictions Assumptions made

Recent changes to schemes not included Changes to eligibility in over 70 year olds January 2009 - 15% reduction post-patent Any future changes to IPHA / APMI

Only public spending

New treatments, changing expectations, changing disease epidemiology not possible to predict

High Tech Arrangements not included

Health system - Challenges

In an overall healthcare context the need to deliver better care for less money

How can access to new and innovative medicines be provided for in the context of an aging population and forecasted declining health expenditure?

Clinical Care & Quality

Deliver better care for less money Chronic disease management

programmes including Asthma Diabetes Cardiovascular diseases

Clinician led Multidisciplinary support

Clinical Care & Quality

Guidelines Structured Care pathways Right Healthcare professional @ right time Early intervention Target resources in these areas Reduce long term complications and

improve population health No overall increase in investment Pharma programme

Medicine Supply:Core Principles 2010

Access to innovative and other medicines through reimbursement based on: affordability sustainability continuity and security of supply value for money

Strategic view / Economic reality

Investment in Innovative medicines

Ensure that any medicine to be reimbursed is cost effective

Health technology assessment

Cost effectiveness and price

No additional funding is expected

Difficult choices ahead

Investment in Innovative medicines

Balance between rapid access to medicines and planned use of scarce resources

Meeting very short timescales specified under current agreements is and will be challenging

May not always be conducive to strategic decision making

Medicines for Orphan Diseases

Should (can) the state pay a premium for orphan medicines particularly those which would not satisfy standard cost effectiveness requirements?

Opportunity costs versus unmet clinical needs

Often a bridge to further therapeutic advances

What is a reasonable premium?

Core Principles

Generate financial headroom to support the predicted growing pharmaceutical needs of an aging population

Allocative decisions must be made in the context of a full understanding of opportunity costs

Increased role of experts in informing decisions about investment in medicines

Financial Headroom

Continue the movement of prices towards the EU average

Maximise the potential of generic market to provide headroom for innovative medicines

Identify medicines which are not cost effective (Health technology assessment)

Financial Headroom

Review all supply chain costs and methods of delivery to identify inefficiencies

Improve Adherence

Improve Efficacy in use

Financial Headroom – efficacy in use

Modern medicines deliver significant benefits to individuals and society

However complications do arise and some of these are avoidable

Priority of the new directorate and DOHC to address patient safety issues

Adverse drug reactions (ADR) as cause of admission to hospital

BMJ 2004 Vol 329; 15 19

Pirmohomad et al. BMJ 2004 Vol 329; 15 19

UK Study

ADR caused 1225 (6.5%) admissions.

107 “definitely avoidable”

773 “possibly avoidable,”

880 might have been avoidable (4.7%)

23 patients died (0.15%)

TORCH:(NEJM 356;8 Feb 22 2007)

A randomised, double-blind trial comparing combination therapy with a long acting

beta agonist (LABA) and inhaled corticosteroids (ICS)

LABA alone ICS alone Placebo

Patients with Chronic Obstructive Pulmonary Disease (COPD) followed over 3 years

TORCH:(ClinicalTrials.gov number, NCT00268216.)

6112 patients, 42 countries, 444 centres

Overall 875 (14.3%) of patients died within the 3 years

All-cause mortality rates 12.6% Combo group 13.5% LABA alone 16% ICS alone 15.2% Placebo

Reduced exacerbations, improved health status and spirometric values

TORCH:POST HOC REVIEW OF ADHERENCE DATA

Adherence to inhaled therapy, mortality and hospital admission in COPD

Post hoc review of TORCH data

Good aherence defined as > 80% use of study medication

Poor adherence defined as < 80%

Vestbo et al Thorax 2009;64:939-943

Vestbo et al Thorax 2009;64:939-943

BMJ 2009;339:b2803

Summary

Innovative medicines important in improving health outcomes

Demonstration of cost effectiveness is required

Financial constraints require that we deliver better care at a lower cost

Optimisation of medicines use can help fund future healthcare needs (and access to new innovative medicines)

Contact Details

Corporate Pharmaceutical Unit,Dr. Steevens' Hospital, Dublin 8.

Telephone: 01-6352672

Email: cpu@hse.ie

http://www.hse.ie/eng/about/Who/Corporate_Pharmaceutical_Unit.html

Thank you